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POSITION SUMMARY: Briefly state the objective of this position.
Performs the role of Local Trial Manager (LTM) including operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents.
May perform the role of Global Trial Manager (GTM) for single country as described in GCO procedural documents.
LTM is a person within Trial Co-ordination and Site Management responsible for local management of a trial (or Medical Affairs data generation activities) in a country or countries. The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs) and regulatory requirements.
LTM actively contributes to process improvement; training and mentoring of Clinical Trial Assistants, Site Managers and LTMs. The LTM may have some site management responsibilities.
PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. List most complex or difficult parts of job first. Describe scope of responsibilities.
1. Is responsible for country do-ability (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and GTM. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
2. Collaborates with the CPL, GTM, local management/Country Head and Protocol Owner to select final site list.
3. Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
4. Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI) and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
5. Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
6. Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints). Uses study tools and management reports available to analyze trial progress
7. Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
8. May submit requests for vendor services and may support vendor selection.
9. May lead negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
10.Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
11.Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
12.Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the GTM and FM as needed
13.Reviews and approves site and local vendor invoices as required
14.Works with SM to ensure CAPP is implemented for audits and inspection or any quality related visits
15.Complies with relevant training requirements.
16.Acts as local expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
17.Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
18.Actively contributes to process improvement; training and mentoring of Clinical Trial Administrators, Site Managers and other LTMs.
Qualifications
EDUCATION AND EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred. Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred. Specific therapeutic area experience may be required depending on the position. Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Good written and oral communication skills.
